Skip to content

The influence of a dietary advice consisting of green vegetables, beef and whole dairy products on subclinical hypothyroidism in children, a randomised controlled trial

The influence of a dietary advice consisting of green vegetables, beef and whole dairy products on subclinical hypothyroidism in children, a randomised controlled trial - Influence of a dietary advice on subclinical hypothyroidism in children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON47234
Enrollment
60
Registered
2015-06-16
Start date
2015-09-15
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

impaired thyroid function Subclinical hypothyroidism

Interventions

5 times a week green vegetables, 3 times a week beef, >300 mL whole milk a day, whole butter on bread every day. Portion sizes are age appropriate.

Sponsors

Medisch Spectrum Twente
Lead Sponsor

Eligibility

Age
2 Years to 11 Years

Inclusion criteria

Inclusion criteria: 1. Age 1-12 years 2. Diagnosis of subclinical hypothyroidism by paediatrician 3. Understanding of Dutch language by parents.

Exclusion criteria

Exclusion criteria: 1. Clinical hypothyroidism (FT4 25) 5. Diabetes Mellitus type 1 6. Cow*s milk allergy. 7. Known or suspected disorder of intestinal absorption (e.g. celiac disease). 8. Disorders requiring a special diet. 9. Any relevant congenital abnormality, anatomical abnormality, chromosomal disorder or severe disease.

Design outcomes

Primary

MeasureTime frame
The main study parameters are (measured with venapunction at 0,3 and 6 months): - TSH-level (measurement with electro-chemiluminescence sandwich immunoassay on a COBAS 6000 (Roche Diagnostics)).

Secondary

MeasureTime frame
- Anti-TPO (venapunction at 0 and 6 months) - Length and weight (at 0, 3 and 6 months) - Tiredness questionnaire, age-dependent for 2-4y, 5-7y, 8-12y and 13-18y (recorded by Pediatric QoL Multidimensional Fatigue Scale, Mapi Research Trust) - Lipid profile (which includes; Total cholesterol, HDL, LDL, chol:HDL ratio, triglycerides) (venapunction at 0, 3 and 6 months). Other study parameters: Parents will receive a questionnaire with various baseline characteristics (e.g. ethnicity, social environment, gestational age, birth weight)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)